Manufacturing problems trigger another clinical hold for troubled Covid-19 vaccine — latest in a string of roadblocks
Just days after the World Health Organization suspended the use of Covaxin after a manufacturing site failed an inspection, the FDA has followed up with a clinical hold on the Covid-19 vaccine’s US co-developer.
Details are in short supply, but the manufacturing site run by Bharat Biotech in India is at the center of the issue after being cited for “deficiencies.” On Tuesday morning, Bharat Biotech’s partner Ocugen reported US regulators had placed a hold on the shot’s Phase II/III study. Bharat Biotech developed the shot and licensed it to Ocugen to co-develop it in the US and Canada.
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